Actively Recruiting
Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients
Led by University of Florida · Updated on 2026-02-17
74
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with breast cancer are commonly treated with taxane chemotherapy. Some very common side effects of taxanes, such as anemia and peripheral neuropathy, are often as not well addressed during treatment, resulting in dose reductions, dose delays and early discontinuation (collectively called relative dose intensity) of these chemotherapy agents in 15-80 % of patients on these drugs. This reduction in relative dose intensity (RDI) results in worse clinical outcomes such as progression free and overall survival. Pre-clinical studies in mouse models subjected to standardized chemotherapy regimens containing paclitaxel or oxaliplatin have shown that the nutritional supplement Epidiferphane reduces both neuropathy and anemia. This study will investigate whether the use of Epidiferphane in patients with breast cancer receiving taxane chemotherapy results in an attenuation of the side effects experienced, as well as an improvement in tumor response rate. The safety and maximum tolerated dose of Epidiferphane in this patient population will also be determined in this study.
CONDITIONS
Official Title
Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be at least 18 years old
- Subjects in phase I must be starting neoadjuvant chemotherapy or have metastatic breast cancer; phase II subjects must have breast cancer of any stage or histology
- Must be starting a taxane regimen at UF Health with one of these doses: paclitaxel weekly 80-90 mg/m2, nab-paclitaxel weekly 75-125 mg/m2 or every 3 weeks 260 mg/m2, or docetaxel every 3 weeks 75-100 mg/m2
- ECOG Performance Status of 3 or less as assessed by the treating physician
- Must continue cancer therapy at UF Health for at least 3 months
- Must not have more than one active malignancy unless approved by the treating physician and principal investigator
- Must have a functioning digestive tract without obstruction
- Must be willing to avoid regular green tea and curcumin supplements during the trial
- Must provide written informed consent and be able to comply with study procedures
- Subjects of childbearing potential must use adequate contraception during the study
- Subjects with partners of childbearing potential must agree to use physician-approved contraception during the study
You will not qualify if you...
- Receiving other investigational agents
- Childbearing potential subjects unwilling or unable to use contraception during the study and for specified times afterward
- Pregnant or breastfeeding
- Active serious systemic infection
- Psychiatric illness or social situations limiting compliance
- Known allergy to turmeric, broccoli, or green tea
- Treatment with strong CYP3A4 inhibitors such as tacrolimus or verapamil during the trial
- History or clinical findings that contraindicate protocol therapy or increase risk of complications as judged by the treating physician
- Prisoners or involuntarily incarcerated individuals
- Compulsorily detained for psychiatric or physical illness
- Inability to comply with study or follow-up procedures
- Peripheral sensory or motor neuropathy grade 2 or higher
- Paresthesia grade 1 or higher
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) over 2.5 times upper limit of normal
- Total bilirubin over 1.5 times upper limit of normal or over 3 times with Gilbert's Syndrome
- Glomerular filtration rate under 50 mL/min
- Red blood cell transfusions within 30 days prior to treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
P
Priya Gurjar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here